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Study on Preventing Acute Kidney Injury in Cardiac Surgery Patients Using Dapagliflozin

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Acute Kidney Injury (AKI), which can occur in patients undergoing heart surgery. The trial will explore the effectiveness of a treatment using a medication called Forxiga, which contains the active ingredient dapagliflozin. This medication is typically used in the form of film-coated tablets. The purpose of the study is to see if this treatment can help prevent AKI in patients who are having certain types of heart surgery.

Participants in the study will be given either the medication or a placebo, and their health will be monitored for a period of time after their surgery. The study will look at how often AKI occurs within seven days after surgery, as well as other health outcomes such as changes in kidney function, heart health, and recovery quality. The study will also track any side effects or complications that may arise from the treatment.

Throughout the study, various health measurements will be taken, including blood sugar levels, heart function, and kidney health. The study aims to provide valuable information on whether the medication can effectively protect the kidneys during and after heart surgery, potentially improving recovery and reducing the risk of serious complications. The trial is expected to continue until June 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed for individuals over 18 years old who are scheduled for elective cardiac surgery with cardio-pulmonary bypass or off-pump coronary artery bypass surgery.

    Informed consent is required to participate in the study.

  2. Step 2

    Medication administration

    The medication used in the study is Forxiga 10 mg film-coated tablets, which contains the active substance dapagliflozin.

    The tablets are taken orally as part of the study protocol.

  3. Step 3

    Surgery and monitoring

    Participants undergo the planned cardiac surgery.

    Monitoring for Acute Kidney Injury (AKI) is conducted for 7 days post-surgery, following the KDIGO criteria.

  4. Step 4

    Postoperative assessments

    Various health parameters are assessed, including kidney function, heart function, and recovery quality.

    Specific assessments include changes in estimated Glomerular Filtration Rate (eGFR), occurrence of atrial fibrillation, and length of stay in the Intensive Care Unit and hospital.

  5. Step 5

    Safety and outcomes evaluation

    Safety outcomes such as infections, diabetic keto-acidosis, and hypoglycemia are monitored.

    Major adverse events related to kidney and cardiovascular health are evaluated.

  6. Step 6

    Completion of study

    The study is estimated to conclude by June 9, 2025.

    Final assessments and data collection are completed to evaluate the effectiveness and safety of the treatment.

Who can join the trial?

3 criteria

  • Must be **over 18 years old**.
  • Must be having **planned heart surgery**. This includes surgery with a machine that helps the heart and lungs work during the operation, known as **cardio-pulmonary bypass (CPB)**, or a type of heart surgery called **off-pump coronary artery bypass surgery (OPCAB)**, which is done without stopping the heart.
  • Must be able to **give informed consent**, meaning you understand the study and agree to participate.

Who cannot join the trial?

4 criteria

  • Individuals who have a history of **AKI** (Acute Kidney Injury), which is a sudden decrease in kidney function.
  • Participants who are not within the specified age range for the study.
  • Individuals who belong to a vulnerable population, which means they might need special protection or care.
  • Participants who do not meet other specific health criteria set by the study.
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Investigated drugs

SGLT-2 Inhibitor is a type of medication used in this trial to help protect the kidneys during heart surgery. It works by blocking a protein in the kidneys, which helps to lower blood sugar levels and may also have protective effects on the kidneys. The goal of using this medication in the trial is to prevent acute kidney injury (AKI) in patients undergoing cardiac surgery.

What is already known about the treatment

Empagliflozin – Empagliflozin is administered orally in tablet form and is currently being studied for its potential to prevent acute kidney injury (AKI) in patients undergoing cardiac surgery. It is well-documented in medical literature as a medication primarily used to manage type 2 diabetes. The main therapeutic indication in this trial is the prevention of AKI. Empagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT-2) in the kidneys, which reduces glucose reabsorption and promotes glucose excretion in the urine. It is classified as an SGLT-2 inhibitor.

Investigated diseases

Acute Kidney Injury (AKI) – Acute Kidney Injury is a sudden episode of kidney failure or damage that happens within a few hours or days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The condition can lead to a decrease in urine output, swelling in the legs, ankles, and around the eyes, and fatigue. It is often detected through changes in blood tests that measure kidney function. AKI can progress to more severe kidney damage if not addressed, but it is sometimes reversible with appropriate care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515260-31-00Estimated enrolment784 patientsSponsorAmsterdam UMC Stichting

sourced from the EU Clinical Trials Register and site verification

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